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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ISRCTN |
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Last refreshed on:
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11 November 2019 |
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Main ID: |
ISRCTN38047922 |
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Date of registration:
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22/04/2014 |
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Prospective Registration:
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No |
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Primary sponsor: |
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Public title:
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Malnutrition in care homes: a feasibility study
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Scientific title:
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A cluster randomised feasibility study evaluating current dietary interventions in the treatment of malnutrition in care home-dwelling adults |
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Date of first enrolment:
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15/12/2013 |
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Target sample size:
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100 |
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Recruitment status: |
Completed |
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URL:
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http://isrctn.com/ISRCTN38047922 |
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Study type:
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Interventional |
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Study design:
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Cluster randomised feasibility trial using a sequential, explanatory mixed method design. Open-label due to the nature of the nutritional interventions under investigation. (Treatment)
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Phase:
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Not Applicable
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Countries of recruitment
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United Kingdom
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Contacts
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Name:
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Ruth
Stow |
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Address:
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Nutrition Support Service
3 The Green
Stratford Road
Shirley
B90 4LA
Birmingham
United Kingdom |
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Telephone:
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+44 (0)121 7464552 |
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Email:
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ruthstow@nhs.net |
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Affiliation:
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Name:
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Address:
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Telephone:
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Email:
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Affiliation:
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Key inclusion & exclusion criteria
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Inclusion criteria:
Local care home that has received dietitian training.
All care home residents that require dietary intervention for malnutrition will receive the randomly allocated dietary plan, provided they meet the following criteria:
1. With/at risk of Disease related malnutrition using the Malnutrition Universal Screening Tool (MUST)
2. Able to eat and drink
3. Registered with a Solihull GP and subsequently eligible for the provision of healthcare services provided by the Heart of England NHS foundation Trust (HEFT)
Exclusion criteria:
Residents will not receive the randomly allocated dietary plan if they:
1. Currently receive (or are likely to receive in the next 6 months) tube or parenteral nutrition
2. Currently receive nutrition support in the form of individualised dietetic advice or prescribed ONS
3. Have a known eating disorder or illness, which requires a therapeutic diet incompatible with fortification and/or supplementation. This may include but is not limited to, Galactosemia or known lactose intolerance, chronic renal disease requiring dialysis, poorly
controlled diabetes, in receipt of active cancer treatment, or liver failure
4. Are on an end-of-life care pathway
Age minimum:
Age maximum:
Gender:
Both
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Health Condition(s) or Problem(s) studied
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Protein care energy malnutrition (PEM) within elderly care home residents
Nutritional, Metabolic, Endocrine
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Intervention(s)
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Dietetic-led intervention arms: Dietitians currently use both food-based intervention and ONS intervention as treatment options for malnutrition within the care home setting.
1. Dietetic led food-based intervention will increase the daily calorie content of the diet by 600kcal and the daily protein content by 20-25g, alongside the standard care home diet for malnutrition, continued for 6 months. The content of the dietary intervention plan will follow locally agreed Nutrition Support guidelines.
2. Dietetic led ONS intervention will increase the daily calorie content of the diet by 600kcal and daily protein content by 24g, alongside the standard care home diet for malnutrition, continued for 6 months. The ONS intervention will use standard liquid sip feeds, in accordance with the local prescribing formulary and enteral feeding contract.
3. Standard, care home intervention arm: The current standard care home diet for malnutrition, without added dietetic intervention, will be delivered to residents for the 6-month period, in line with the training already provided to care home staff (including catering teams) by the Registered Dietitian. The purpose of the standard dietary intervention is to provide and encourage a calorie dense diet, which may be achieved through provision of small, frequent meals, recipe enrichment with additional calories and prompting and assistance from care home staff where required.
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Primary Outcome(s)
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1. The outcome measures collected within usual monitoring, such as change in energy intake and anthropometric parameters (weight, BMI, handgrip strength and MAMC) will continue to be collected for all residents with, or at risk of malnutrition that are placed onto a dietary plan.
2. A healthcare resource-usage questionnaire will be trialled by care home staff within this study to inform the development of a malnutrition specific instrument for the future trial.
3. For residents who have the capacity to consent to join the study, additional outcome measures will be collected, including: participant-reported quality of life (CO-OP Charts), health state (EQ-5D questionnaire), and participant rated appetite and dietary satisfaction (VAS tool).
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Secondary Outcome(s)
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Interviews with a sample of residents and focus groups with care home staff will complement the quantitative data collection by further exploring the feasibility and acceptability of the study design.
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Secondary ID(s)
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R&D Project code: 2013102EM
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Source(s) of Monetary Support
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Investigator initiated and funded.
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Ethics review
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Status:
Approval date:
Contact:
NRES Committee West Midlands - Edgbaston, 23/09/2013, ref. 13/WM/0390
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Results
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Results available:
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Yes |
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Date Posted:
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Date Completed:
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30/09/2014 |
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URL:
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